Evaluation of hypoallergenicity of a new, amino acid-based formula

Clin Pediatr (Phila). 2015 Mar;54(3):264-72. doi: 10.1177/0009922814557785. Epub 2014 Nov 12.


The American Academy of Pediatrics (AAP) defined a formula as hypoallergenic if it ensures with 95% confidence that 90% of infants with confirmed cow's milk allergy (CMA) will not react with defined symptoms under double-blind, placebo-controlled conditions. This study's objective was to determine whether a new amino acid-based formula (AAF) meets the AAP hypoallergenicity criteria.

Methods: Children with CMA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new AAF and a commercial AAF in crossover fashion followed by an at-home open challenge with the new AAF. Allergic reactions were assessed using a scoring system.

Results: Thirty-three subjects completed DBPCFCs with both formulas without acute allergic reactions. The lower bound 95% confidence interval for hypoallergenicity was 91.3%. No unusual stool patterns, allergic symptoms, or signs of intolerance were reported during the open challenge.

Conclusion: . The new AAF meets AAP hypoallergenicity criteria and can be recommended for the management of CMA.

Keywords: cow’s milk allergy; hypoallergenic; infant formula.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amino Acids / administration & dosage*
  • Child
  • Child, Preschool
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Infant Formula / methods*
  • Male
  • Milk Hypersensitivity / diet therapy*


  • Amino Acids